Adenosine and Magnesium Sulphate as Adjuvants for PECS Block.
- Conditions
- Breast Surgery
- Interventions
- Registration Number
- NCT03344679
- Lead Sponsor
- Menoufia University
- Brief Summary
Pectoral nerve block (PECS) has been used for post-operative pain relief in patients undergoing breast surgery. It has been shown that adenosine has an effect on pain modulation. Magnesium sulphate has been used as an adjuvant to local anaesthetics in many nerve block techniques. We hypothesised that adenosine may affect the PECS block quality. We aimed to compare the effect of adding adenosine to the local anaesthetic and compare its effect to magnesium sulphate when used for PECS block.
- Detailed Description
The present study was conducted on 90 adult patients aged between 20 and 65 years old. Patients scheduled for modified radical mastectomy with axillary clearance surgery American Society of Anaesthetist (ASA) classes I, II, and III patients were included in the study.
Patients were randomly allocated into on of three groups according to the adjuvant used with the local anaesthetic, 30 patients in each group using a computerised program. All patients received PECS block. Group (C) received PECS block with 0.25% bupivacaine (control group), group (A) bupivacaine with added adenosine, and group (M) bupivacaine with added magnesium sulphate.
The local anaesthetic syringes were prepared by an independent anaesthetist. The researchers and the patients were blinded to the local anaesthetic adjuvant in the syringes. All patients received 30 ml local anaesthetic for PECS. The 30 ml local anaesthetic used for each patient contained bupivacaine hydrochloride 0.25%, bupivacaine hydrochloride 0.25% and 12 mg adenosine, and bupivacaine hydrochloride 0.25% and 500 mg magnesium sulphate for groups C, A, and M respectively.
Patients' demographic data were collected including age, BMI, ASA, and duration of surgery. In the post- anesthetic care unit (PACU) the visual analogue score (VAS) was assessed on arrival and then every 15 minutes. The duration and the quality of the block was recorded.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 90
- Patients scheduled for modified radical mastectomy with axillary clearance surgery ASA classes I, II, and III patients were included in the study
-
- contraindications for regional anesthesia such as coagulopathy, local infection and fungating breast cancer, 2) history of allergy to the medications used in the study, 3) patient with history of drug abuse, 4) previous breast surgery except for diagnostic biopsies, 5) history of treatment for a chronic pain condition, 6) psychiatric disorder.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Adenosine Bupivacaine 0.25% Bupivacaine 0.25% with added Adenosine 12mg for pectoral nerve block. Adenosine Adenosine 12mg Bupivacaine 0.25% with added Adenosine 12mg for pectoral nerve block. Control group Bupivacaine 0.25% Bupivacaine 0.25% for pectoral nerve block. Magnesium sulphate Bupivacaine 0.25% Bupivacaine 0.25% with Magnesium sulphate 500 mg for pectoral nerve block. Magnesium sulphate Magnesium Sulphate 500 mg Bupivacaine 0.25% with Magnesium sulphate 500 mg for pectoral nerve block.
- Primary Outcome Measures
Name Time Method Visual analogue scale (VAS) First 24 hours after surgery Visual analogue scale is a scale from 1 to 10 where 1 is no pain and 10 is the worst pain the patient experienced.
- Secondary Outcome Measures
Name Time Method Mean arterial blood pressure (mmHg) Intra-operative (from induction of anaesthesia until the patient is awake) Mean arterial blood pressure reading.
PECS block duration. First 24 hours after surgery The time from performing the block until the patient started to feel pain and the effect of the block faded.
Heart rate (beat/minute) Intra-operative(from induction of anaesthesia until the patient is awake) The number of hear beats per minute
Analgesic requirement First 24 hours after surgery The total amount of morphine (mg) consumed by patients.